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Completed

NCT Number: NCT05503212

Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral Artery Occlusions

Isolated vertebral artery occlusions (VAO) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. If the two recent ATTENTION and BAOCHE randomized clinical trials have proven the superiority of endovascular thrombectomy (EVT) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated VAO is scarce. We aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated VAO.

In the absence of RCT, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. Results may also lay the basis for prospective studies, such as randomized clinical trials.

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Key information

Conditions

Ischemic Stroke Arterial Occlusive Diseases Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases Vertebral Artery Ischemia Vertebrobasilar Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke limited to the posterior circulation
  • Presence of uni- or bilateral VAO (intracranial and/or extracranial) on at least one initial imaging study (CTA, MRA, DSA)
  • IVT, EVT or bridging-treated stroke patients between 01.01.2003 and 31.12.2021
  • ≥ 18 years old

Exclusion criteria

  • Extension of the occlusion into the basilar artery
  • Presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions)
  • Previously known chronic occlusion of the any segment of the vertebral artery/arteries
  • Local ethical/legal conditions in participating center not fulfilled

Treatment and study plan

Conservative treatment (CT)

Other

Best medical treatment without intravenous thrombolysis nor endovascular thrombectomy

Intravenous thrombolysis (IVT)

Other

Best medical treatment with intravenous thrombolysis but without endovascular thrombectomy

Endovascular thrombectomy (EVT) ± intravenous thrombolysis (IVT)

Other

Best medical treatment with endovascular thrombectomy with or without intravenous thrombolysis

Primary outcomes

  1. 3-month modified Rankin scale

    Time frame: 90 days

    3-month functional outcome, [range: 0-6, 0= no symptoms, 6=death]

Secondary outcomes

  1. Symptomatic intracerebral haemorrhage (sICH)

    Time frame: 7 days

    Any hemorrhagic transformation temporally related to any worsening in neurological condition. [yes/no]

  2. EVT procedural complications

    Time frame: During EVT procedure or peri-procedural

    Any complication attributed to the procedure (vessel perforation, vasospasm, dissection, Subarachnoid haemorrhage (SAH)/Intracerebral haemorrhage (ICH), device detachment/misplacement, embolization to new territory, access-site complications, early reocclusion, other)

  3. 24-hour NIHSS

    Time frame: 24 hours

    NIH Stroke Scale/Score (NIHSS). Quantifies stroke severity based on weighted clinical evaluation findings at 24h. [0-42, 0= no deficit, 42=maximum stroke severity]

  4. Early neurological deterioration (ENDi)

    Time frame: 24 hours

    Early neurological deterioration of ischemic origin (ENDi) is defined as an increase in National Institute of Health Stroke (NIHSS) score ≥ 4 points or death within 24 hours. [yes/no]

  5. Cerebrovascular ischemic recurrences

    Time frame: 90 days

    Any ischemic stroke or transient ischemic attack recurrence [yes/no]

  6. 24h and 3month mortality

    Time frame: 24h and 90 days

    Mortality at 24h and 3 months

  7. Vessel recanalisation on follow up-imaging

    Time frame: 48 hours

    Vessel recanalisation at follow-up imaging (0= no recanalisation, 1= partial recanalisation 50-99%, 2=full recanalisation, 3= initially not occluded)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • Asan Medical Center
  • Azienda Ospedaliero-Universitaria di Modena
  • Azienda USL Reggio Emilia - IRCCS
  • Boston Medical Center
  • Charite University, Berlin, Germany
  • Clinical Centre of Serbia
  • Corewell Health West
  • Duke University
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Hadassah Medical Organization
  • Helsinki University Central Hospital
  • Hospital Vall d'Hebron
  • Hospital de Egas Moniz
  • Insel Gruppe AG, University Hospital Bern
  • Ludwig-Maximilians - University of Munich
  • Medical University Innsbruck
  • Neurocenter of Southern Switzerland
  • Sahlgrenska University Hospital
  • St John of God Hospital, Vienna
  • The Cooper Health System
  • The University of Texas Health Science Center, Houston
  • University Hospital Carl Gustav Carus
  • University Hospital, Basel, Switzerland
  • University Hospital, Geneva
  • University Hospital, Lille
  • University of Zurich
  • Università degli Studi di Brescia
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

Best Revascularisation Approach for Posterior Circulation Strokes With Isolated Vertebral : the BRAVO Retrospective Analysis

Acronym: BRAVO

Important dates

Study start
2003
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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